Instrumentation for endoscopic surgical insertion and application of liquid, gel and like material

ABSTRACT

An endoscopic instrument includes an inner elongated instrument member that fits the bore of an outer elongated instrument member. The outer elongated instrument member includes a slot through which a surgical sheet material can be pulled so as to furl the material within the instrument. The slot can vary in length and width accommodating various surgical sheet material sizes. The slot can also be open ended or closed and its length and width can be varied accommodating different sizes and thicknesses of sheet material. The inner instrument member can include a flag that can be furled about the distal end portion of the inner instrument member and for attachment to the sheet of surgical material. The outer instrument member includes an articulating end portion that can be moved to deflect the end portion of the inner instrument member such as when the flag is unfurled inside a patient&#39;s body cavity.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation-in-part of U.S. Ser. No. 09/376,803, filed Aug. 18, 1999 now U.S. Pat. No. 6,416,506, which is a continuation-in-part of U.S. Ser. No. 09/021,564, filed Feb. 10, 1998 (now U.S. Pat. No. 6,010,495, issued Jan. 4, 2000), which is a continuation-in part of U.S. Ser. No. 08/718,861, filed Sep. 24, 1996 (now U.S. Pat. No. 5,797,899, issued Aug. 25, 1998), which is a continuation-in-part of U.S. patent application Ser. No. 08/644,504, filed May 10, 1996 (now U.S. Pat. No. 5,766,157, issued Jun. 16, 1998), which is a continuation-in-part of U.S. patent application Ser. No. 08/625,098, filed Apr. 1, 1996, now U.S. Pat. No. 5,919,184, which is a continuation-in-part of U.S. patent application Ser. No. 08/407,409, filed Mar. 17, 1995 (now U.S. Pat. No. 5,503,623, issued Apr. 2, 1996), all of which are incorporated herein by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not applicable

REFERENCE TO A “MICROFICHE APPENDIX”

Not applicable

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a method and apparatus for endoscopic surgical (endo-surgical) introduction and application of surgical sheet material.

2. General Background of the Invention

Surgery performed within a body cavity (e.g., chest cavity, abdominal cavity) by means of endoscopic surgery utilizes of one or more surgical entry “ports” in varying size. The majority of sizes is in the range of five (5) millimeters to fifteen (15) millimeters, but may be as small as approximately two (2) millimeters. Each port consists of a tube with proximal and distal ends. A valve structure on the proximal end of the port member allows instruments to be passed through the body cavity wall while maintaining appropriate intra-cavity CO₂ (or other gas) pressure (if such pressure is required).

While instruments pass easily through the associated port member and its valve structure, sheet like material, liquids, gels, and like medicinal materials cannot be easily administered in endoscopic surgery.

In endoscopic surgery, there are or will be a variety of sheet material, liquid, gel and like medicinal materials that require application in the body cavity (including the pelvis). Because these products have specific medical purposes (example: adhesion prevention and as a drug delivery vehicle) the application will have to be precise (to targeted areas or tissues) as opposed to the general way irrigating solutions are administered to wash or rinse tissues during surgery. Also, because these products will be expensive they cannot be wasted and precise application is desired.

BRIEF SUMMARY OF THE INVENTION

The present invention provides an improved instrument for endoscopic surgical insertion and application of a surgical sheet material. The present invention also provides a method of placing a surgical sheet material into a patient's body cavity such as, for example, the abdominal cavity, chest cavity, or the like.

The present invention provides an endoscopic surgical instrument that includes an outer elongated instrument body having an open ended bore and proximal and distal end portions. An inner elongated instrument body fits inside the bore of the outer instrument body, the inner instrument body having proximal and distal end portions, at least the distal end portion being flexible or articulated.

In one embodiment a flag member is mounted to the distal end of the inner instrument member, the flag member being sized and shaped to support a sheet of surgical material to be placed within the body cavity of a patient.

An optional articulating joint is provided at the distal end portion of the outer instrument body. The combination of the distal end of the inner instrument body and the flag furled about the distal end can be fitted within the bore of the outer instrument body of the distal end portion thereof. Means is provided for deploying the distal end of the inner instrument member beyond the distal end of the outer instrument member so that the flag can be opened to deploy the sheet of material inside the patient's body cavity. The joint is preferably an articulating joint that can include a pivot.

The flag member is preferably a plastic material having a memory (or a preloaded cartridge) so that it automatically opens when the flag is discharged beyond the distal end of the outer instrument body into the patient's body cavity. This action opens the flag and presents the sheet of material to the proper location within the patient's body cavity.

The outer instrument body can include a slot, open-ended or closed-ended, that receives a surgical sheet material and/or the flag member so that sheet and/or the flag member can be furled about the inner instrument member and inside the bore of the outer instrument member by rotating the inner and outer instrument members in opposite relative rotational directions.

A clamp can be provided for holding an edge of the surgical sheet on the flag next to the inner instrument member. The clamp is preferably a U-shaped member that fits the instrument member for gripping the edge of the surgical sheet material that the surgeon places on the flag.

A trigger mechanism is provided for pulling the clamp in order to release the sheet material once inside the patient's body cavity.

The inner instrument body can be provided with a plurality of openings, preferably linearly arranged. The openings can be subjected to suction for holding the material to be dispensed to the inner instrument member. The material to be dispensed can then be released by releasing the suction. The openings can also function as dispensing openings for dispensing a volume of liquid (such as normal saline). The liquid (e.g. saline) flows through the holes causing the sheet like material to “float” off, or detach from the flag member. This feature may be required when the sheet like material is stuck to the flag member by a small static or van der Waal type interaction present between the material and the flag. When using the linearly arranged openings, the U-shaped clamp or hood may not be required.

BRIEF DESCRIPTION OF THE DRAWINGS

For a further understanding of the nature and objects of the present invention, reference should be had to the following detailed description, taken in conjunction with the accompanying drawings, in which like parts are given like reference numerals, and wherein:

FIG. 1 is a perspective exploded view of a preferred embodiment of the apparatus of the present invention;

FIG. 2 is a side elevational view of the embodiment in FIG. 1;

FIG. 3 is a top plan view of the embodiment in FIG. 1;

FIG. 4 is a perspective fragmentary view of the embodiment in FIG. 1;

FIG. 5 is a partial sectional view of the embodiment in FIG. 1;

FIG. 6 is a perspective view of the embodiment in FIG. 1 showing the flag portion in an extended position;

FIG. 7 is a fragmentary side view of the embodiment in FIG. 1 illustrating deployment of the flag portion;

FIG. 8 is a partial perspective view of the embodiment in FIG. 1 illustrating connection of the surgical sheet material to the distal end portion of the inner instrument member;

FIG. 9 is a partial perspective view of the preferred embodiment of the embodiment in FIG. 1 showing attachment of the surgical sheet material to the distal end portion of the inner instrument member;

FIG. 10 is a partial perspective view of the embodiment in FIG. 1 showing the distal end portion of the inner instrument member and its use in moving the surgical sheet material during a surgical procedure;

FIG. 11 is a fragmentary view illustrating schematically the use of the distal end portion of the inner instrument member to move the surgical sheet material during surgery;

FIG. 12 is a fragmentary view illustrating schematically the use of the distal end portion of the inner instrument member to move the surgical sheet material during surgery;

FIG. 13 shows a perspective view of an alternative embodiment having a closed ended slot; and

FIG. 14 is a side view of the embodiment shown in FIG. 13.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1-7 show a preferred embodiment of the apparatus of the present invention designated generally by the numeral 10 in FIGS. 1-3. Endoscopic surgical instrument 10 includes an inner instrument member 11 and an outer instrument member 12, the inner member 11 preferably being flexible and the outer member 12 being articulated. The outer instrument 12 includes a proximal end portion 25, a distal end portion 26, and a slot 34.

Outer instrument member 12 provides a jointed portion that is preferably an articulating joint 27. Joint 27 can be operated with lever 28 to move in a pivotal fashion as shown by arrows 33 in FIG. 3. The use of lever 28 to operate distal end portion 26 of outer instrument body 12 is illustrated by arrow 17 in FIG. 2 and can be seen in prior U.S. Pat. Nos. 5,503,623; 5,766,157; 5,797,899; 5,919,184; and 6,010,495 and in co-pending patent application Ser. No. 09/376,803, all of which are hereby incorporated herein by reference.

As shown in FIG. 1, slot 34 can begin at proximal end 34 a and be open-ended at distal end 34 b. In FIG. 2, slot 34 is also shown as beginning at proximal end 34 a and is open-ended at distal end 34 b. In an alternative embodiment, shown in FIGS. 13 and 14, slot 34 can begin at proximal end 34 a and be closed-ended at distal end 34 c. In both embodiments, proximal end 34 a can be located anywhere along distal end 26 to vary slot length to accommodate different sizes of sheets of surgical material. Additionally, the width or height of slot 34 can be varied to accommodate different thicknesses of sheets of surgical material 15.

In FIG. 1 of U.S. Pat. No. 5,503,623, the jaws open and close in parallel; opening and closing could be scissors-like in action, though opening and closing in parallel is preferred. Inner instrument member 11 has proximal end 29 with handle 30 and distal end 23.

A flag 13 of preferably rectangular shape can be supported at the distal end portion 23 of inner instrument member 11 as shown in FIG. 1. In one embodiment flag 13 is attached to the inner instrument member 11 so that when the inner instrument member 11 is rotated, flag 13 will furl about the distal end portion 23 of the inner instrument member 11. Flag 13 can be of a material such as polypropylene or polyethylene among others.

Envelope 14 is preferably a disposable envelope that contains a surgical sheet material 15 to be implanted in the patient. This surgical sheet material can be, for example Seprafilm® (Genzyme), Interceed® (Johnson & Johnson), Repel® (Life Medical), Incert® (Anika) or other hyaluronic acid or collagen derived materials. Some materials do not require an envelope, so envelope 14 is optional in some cases.

Surgical sheet material 15 provides an edge 16 to be attached to flag member 13 that is supported by distal end portion 23 of inner instrument member 11. Alternatively, some surgical sheet material (for example Seprafilm®) will adhere to the plastic flag 13 without the need to attach edge 16 to inner instrument member 11.

In FIGS. 1, 5 and 8-9, a U-shaped clamp or hood 20 can be used to connect the edge 16 of surgical sheet material 15 to the distal end portion 23 of instrument member 11. In FIGS. 1 and 8-9, it can be seen that the edge 16 of sheet material 15 can be held to the distal end 23 of inner instrument member 11 with U-shaped hood 20. The U-shaped hood 20 provides a longitudinally extending recess 21 surrounded by a U-shaped or C-shaped wall 22.

Distal end 26 of outer instrument member 12 provides slot 34 through which flag member 13 extends when it is unfurled. The slot 34 also receives edge 16 so that the combination of sheet of material 15 and flag 13 can be furled (see arrow 37 in FIG. 4) about distal end portion 23 of inner instrument member 11 inside bore 18 of outer instrument member 12.

Furling (see FIG. 4) can be accomplished by holding the outer instrument member 12 while rotating the inner instrument member 11 so that the flag member 13 and the attached surgical sheet material 15 furl about the distal end portion 23 of inner instrument member 11. During furling of the flag member 13, surgical sheet material 15 rests upon surface 19 of flag 13 and is wrapped with the flag 13 about distal end portion 23 of inner instrument member 11. During a surgical procedure, the surgeon places the assembly of inner instrument member 11 and flag member 13 with sheet 15 into the bore 18 of outer instrument member 12. The bore 18 can be open ended, extending the full length of outer instrument member 12 between its end portions 25, 26. Inner instrument member 11 fits within the bore 18 of outer instrument member 12 so that the overall assembly can be inserted through a standard endoscopy port (not shown) for surgery.

Flag member 13 carrying surgical sheet material 15 furled about inner instrument member 11 is positioned at the distal end 23 and within bore 43. The proximal end 29 of inner instrument member 11 provides a handle 30 that can aid in moving inner instrument member 11 into the bore 18 of outer instrument member 12. Handle 30 also enables inner instrument member 11 to be slided with respect to outer instrument member 12. An elongated slot on outer instrument body 12 proximal end 25 can receive handle 30. This enables handle 30 to extend distal end 23 of inner instrument member 11 beyond the distal end 26 of outer instrument member 12 such as during furling (see arrows 36, FIG. 4). The assembly of these two members 11, 12 is shown in FIGS. 1, 2 and 3.

The trigger end portion of the apparatus 10 can be any ergonomically designed arrangement that includes the control and positioning portions of the apparatus of the present invention. This would also include the trigger mechanism such as the pull ring 35.

Inner instrument member 11 has a bore 31 that carries cable 32. The cable 32 is used to deploy the flag member 13 and a surgical sheet material 15 mounted thereon, once the surgeon has placed the distal end portion 23 of the inner instrument member 11 through the endoscopy port and into the patient's body cavity for placement.

In FIGS. 6-7, the flag member 13 can be opened to dispense surgical sheet material 15 by pulling ring 35 and its attached cable 32. Ring 35 and cable 32 are pulled in the direction of arrows 38 in FIGS. 6-7. Cable 32 pulls U-shaped hood 20 from flag 13 and sheet 15. The flag 13 can be of a plastic material that has a memory so that it opens once distal end portion 23 of inner instrument member 11 is extended beyond distal end 26 of outer instrument member 12, as indicated schematically by arrow 39 in FIG. 7. In FIG. 4, arrows 36 show the distal end of the inner instrument member 11 containing flag 13 and surgical sheet material 15. Flag 13 and surgical sheet material 15 unfurl due to the memory of the flag 13 which has the surgical sheet material 15 attached to it. This is also shown in FIGS. 5, 6 and 7. Arrow 39 in FIG. 7 schematically indicates the unfurling of surgical sheet material 15 from flag 13 when ring 32 is pulled in the direction of arrows 38 in order to remove U-shaped hood 20 from flag 13 and surgical sheet material 15. As shown in FIG. 7 of U.S. patent application Ser. No. 09/021,564 the nozzle can have an array of openings spaced along one side portion of the nozzle.

In FIGS. 8-9, distal end portion 23 of inner instrument member 11 can be provided with a plurality of openings 24. Fluid can be transmitted to openings 23 via a central bore of inner instrument body 11 for assisting in the removal of sheet 15 from flag 13 by flowing the fluid over surface 19 of flag 13, washing sheet 15 therefrom.

The openings 24 are preferably linearly arranged as shown in FIGS. 8 and 9. The linearly arranged holes 24 can be used either for holding the surgical sheet material 15 in place or for delivering a small volume of liquid (such as normal saline) through the holes 24. The dispensed liquid such as saline causes the sheet like material 15 to “float” off or detach it from the flag member 13. At times, the surgical sheet like material 15 can become stuck to the flag because of a small static or van der Waal type interaction present between the material 15 and flag 13. For this type of material, the U-shaped clamp 20 may not be necessarily required for the apparatus 10 to function properly.

In FIGS. 10-12, a suction via flowline 40 can be pulled in the direction of arrows 41, 42 so that openings 24 can be used to grip and manipulate sheet 15 once it is surgically placed inside of a patient's body cavity.

The following table lists the parts numbers and parts descriptions as used herein and in the drawings attached hereto.

PARTS LIST Part Number Description 10 surgical instrument 11 inner instrument member 12 outer instrument member 13 flag member 14 envelope 15 surgical sheet material 16 edge 17 arrow 18 bore 19 surface 20 U-shaped hood 21 recess 22 wall 23 distal end 24 opening 25 proximal end 26 distal end 27 articulating joint 28 lever 29 proximal end 30 handle 31 bore 32 cable 33 arrow 34 slot 34a proximal end 34b distal end 34c distal end 35 pull ring 36 arrow 37 arrow 38 arrow 39 arrow 40 conduit 41 arrow 42 arrow

The foregoing embodiments are presented by way of example only; the scope of the present invention is to be limited only by the following claims. 

1. An endoscopic surgical instrument comprising: a) an outer elongated instrument body having an open ended bore and proximal and distal end portions; b) an inner elongated instrument body that fits inside the bore of the outer instrument body, the inner instrument body having proximal and distal end portions, at least the distal end portion being flexible; c) a slot in the elongated outer instrument body located closer to the distal end portion, the slot being sized and shaped to allow passage of a sheet of surgical material to be placed within the body cavity of a patient; d) an articulating joint at the distal end portion of the outer instrument body; e) wherein the combination of the distal end of the inner instrument body and the surgical sheet of material can be fitted within the bore of the outer instrument body at the distal end portion thereof; and f) means for deploying the distal end of the inner instrument member beyond the distal end of the outer instrument member so that the sheet material can be deployed inside the patients body cavity.
 2. The surgical endoscopic instrument of claim, 1 wherein the slot is open ended.
 3. The surgical endoscopic instrument of claim 1, wherein the slot is closed ended.
 4. The surgical endoscopic instrument of claim 2, further including a flag member mounted being sized and shaped to support the sheet of surgical material.
 5. The surgical endoscopic instrument of claim 3, further including a flag member mounted being sized and shaped to support the sheet of surgical material.
 6. The surgical endoscopic instrument of claim 1 wherein the joint includes a pivot.
 7. The surgical endoscopic instrument of claim 4 wherein the flag is plastic.
 8. The surgical endoscopic instrument of claim 5 wherein the flag is plastic.
 9. The surgical endoscopic instrument of claim 1 further comprising a clamp for holding the edge of a sheet of surgical sheet material on the distal end portion of the inner instrument member.
 10. The surgical endoscopic instrument of claim 4 further comprising means for holding the sheet of surgical sheet material on the flag.
 11. The surgical endoscopic instrument of claim 5 further comprising means for holding the sheet of surgical sheet material on the flag.
 12. The surgical endoscopic instrument of claim 1 further comprising a u-shaped clamp that fits the outer surface of the inner instrument member for gripping the edge of a sheet of surgical sheet material.
 13. The surgical endoscopic instrument of claim 9 further comprising a trigger for pulling the clamp in order to release the sheet material from the flag.
 14. The surgical endoscopic instrument of claim 1 wherein the sheet of surgical material is in the form of a pre-loaded cartridge.
 15. An endoscopic surgical instrument comprising: a) an outer elongated instrument body having an open ended bore and proximal and distal end portions; b) an inner elongated instrument body that fits inside the bore of the outer instrument body, the inner instrument body having proximal and distal end portions, at least the distal end portion being flexible; c) a surgical sheet-like material to be deployed, the sheet like material being furled during use about the distal end of the inner instrument member; d) a slot in the elongated outer instrument body located closer to the distal end portion, the slot being sized and shaped to allow passage of the sheet of surgical material to be placed within the body cavity of a patient; e) a flag attached to the distal end of the inner instrument member; f) dispensing openings on the distal end of the inner instrument member, the dispensing openings positioned to dispense fluid to the sheet like material and deploy it; an articulating joint at the distal end portion of the outer instrument body; h) wherein the combination of the distal end of the inner instrument body and the surgical sheet like material furled about the said distal end can be fitted within the bore of the outer instrument body at the distal end portion thereof; and i) means for deploying the distal end of the inner instrument member beyond the distal end of the outer instrument member so that the flag can be opened to deploy the sheet material inside the patients body cavity.
 16. The surgical endoscopic instrument of claim 15 wherein the joint includes a pivot.
 17. The surgical endoscopic instrument of claim 15 wherein the inner instrument member has a bore to which a vacuum can be attached for drawing a vacuum on the dispensing surgical sheet like openings so that material can be gripped.
 18. The surgical endoscopic instrument of claim 15 wherein the member has a bore that can receive fluid to be transmitted to the dispensing openings.
 19. The surgical endoscopic instrument of claim 15 further comprising a source of vacuum attachable to the proximal end portion of the inner instrument member.
 20. The surgical endoscopic instrument of claim 15 further comprising a source of liquid that flows into the combination of inner and outer instrument bodies during said deployment.
 21. The surgical endoscopic instrument of claim 20 further comprising a suction attachable to the combination of inner and outer instrument bodies for enabling a surgeon to manipulate the surgical sheet like material with the dispensing openings.
 22. An endoscopic surgical instrument comprising: a) an outer elongated instrument body having an open ended bore and proximal and distal end portions; b) an inner elongated instrument body that fits inside the bore of the outer instrument body, the inner instrument body having proximal and distal end portions, at least the distal end portion being flexible; c) a sheet of surgical material to be placed within the body cavity of a patient, said sheet of material being removably attached to the inner instrument body; d) a slot in the elongated outer instrument body located closer to the distal end portion, the slot being sized and shaped to allow passage of the sheet of surgical material to be placed within the body cavity of a patient; e) an articulating joint at the distal end portion of the outer instrument body, the distal end of the inner instrument member flexing distally of the articulating joint inside the distal end of the outer instrument member when the joint articulates; and f) a source of fluid removably attachable to the inner instrument body for enabling a surgeon to manipulate and deploy the sheet of material inside a patients body cavity. 